Application 209855

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209855-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2024-05-29
A209855-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2024-05-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209855-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209855-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-002	AB1	1	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d1aa4690-57b5-4a3e-ac12-85f777dbd05e	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
RELGAABI	GABAPENTIN	Method Pharmaceuticals, LLC	4cc6615b-5447-9c0e-e063-6394a90a2883	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	798575b9-ddfa-4915-9574-626abbaf025f	2026-04-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75caca13-1432-4c0d-8d45-f029b0b2d417	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56378630-e7a7-4981-8212-8ea703a433d8	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	4ddc1342-5c83-f562-e063-6294a90a29ba	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc83432-8fce-6d2a-e053-2a95a90ae73f	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	81774da8-cb1d-4c7d-8550-35396850d5ff	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Radha Pharmaceuticals, Inc.	1045db4e-4c76-4a0d-bf12-019bd96a8f59	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	0b286fd1-8179-d87a-e063-6294a90a2f23	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	American Health Packaging	e00f5048-1a06-44f4-b244-aa2755f4be22	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Solco Healthcare US, LLC	360d953b-4313-45ae-b933-296547d4577d	2026-02-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	54c09aa5-6724-480a-a115-c88484e39e93	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advagen Pharma Ltd	401b30fc-e143-4906-aae1-e5b5c190d4a8	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advagen Pharma Ltd	bfee67dc-d2b1-4a00-92d9-a42be3189c74	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	5ab9c18b-9568-4dcb-90b0-252aef8f8dc2	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9814b76c-87c6-4746-b712-3269352a901b	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.